Serum Estradiol (E2) Levels in Breast Cancer Patients During Endocrine Therapy by High Performance Liquid Chromatography-tandem Mass Spectrometry (LC-MS /MS)

Recruiting

• Conditions: Breast Cancer
• Interventions: Drug: FUL; Drug: AIs; Drug: OFS+AIs

• Registration Number: NCT06195202
• Lead Sponsor: Sun Yat-sen University

Brief Summary

The investigators intend to conduct a prospective cohort study to detect E2 levels during endocrine therapy in Chinese breast cancer patients using LC-MS/MS methods, and to determine the proportion of patients with premenopausal E2 levels (OFR or E2 insufficiency) during AIs or FUL endocrine therapy. To further explore the correlation between serum E2 levels and the efficacy of endocrine therapy in Chinese patients, so as to ensure the safety and efficacy of endocrine therapy for patients, and pave the way for further providing more accurate individualized treatment programs.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-01
• Status Verified: 2023-12
• Study First Submitted: 2023-12-24
• Study First Submitted QC: 2024-01-05
• Last Update Submitted: 2024-01-07
• Study First Posted: 2024-01-08
• Last Update Posted: 2024-01-09
• Primary Completion: 2024-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 2000

Inclusion Criteria

• Over 18 years old;
• Histologically confirmed breast cancer;
• Patients with early breast cancer (including natural menopause and artificial menopause using LHRHa), or patients with advanced breast cancer (including natural menopause and artificial menopause using LHRHa) who use AIs (letrozole, anastrozole or exemestane) as adjuvant endocrine therapy, First-line CDK4/6 inhibitors (Palbociclib, Dalpiciclib, Abemaciclib or Ribociclib) +AI endocrine therapy, second-line CDK4/6 inhibitors (Palbociclib, Dalpiciclib, Abemaciclib or Ribociclib) + fluvestrant (FUL) endocrine therapy;
• Patients with needs for hormone testing;
• Standard treatment, complete clinical data, including complete efficacy evaluation and follow-up data.

Exclusion Criteria

• Breast cancer patients using TAM endocrine therapy;
• In advanced patients, AIs exceeded first-line use (that is, in advanced disease, one endocrine therapy regimen had been used and failed), and FUL exceeded second-line use (that is, more than one endocrine therapy regimen had been used and failed)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
FUL	FUL	Patients with FUL
AI	AIs	Patients with AIs
OFS+AI	OFS+AIs	Patients with OFS+AIs

Primary Outcome Measures

Name	Time	Method
The serum E2 levels in breast cancer patients during endocrine therapy.	From enrollment to 1 months	Consistency between 2 methods

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China